Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 008565
Company: WYETH AYERST
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
THIOSULFIL SULFAMETHIZOLE 250MG TABLET;ORAL Discontinued None No No
THIOSULFIL SULFAMETHIZOLE 500MG TABLET;ORAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/28/1953 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/17/1988 SUPPL-21 Labeling

Label is not available on this site.

12/30/1987 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/17/1980 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

06/26/1980 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

03/16/1979 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

09/22/1978 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

01/31/1978 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

06/01/1978 SUPPL-9 Labeling

Label is not available on this site.

07/25/1977 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

12/23/1976 SUPPL-7 Manufacturing (CMC)-Formulation

Label is not available on this site.

01/20/1976 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

11/04/1974 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

11/04/1974 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

03/26/1975 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

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